Protocol Number: 09-I-0013
At present, the pathophysiology underlying the association of elevated D-dimer concentrations with mortality in HIV is not understood. This study seeks to identify possible mechanisms underlying D-dimer elevations in HIV-infected adults by investigating a number of pathways that may be associated with the elevations using biomarkers of inflammation, hemostasis, thrombosis, platelet function, lipid metabolism, and additional indicators of endothelial function. Further elucidation of plausible pathways contributing to D-dimer elevation could, ultimately, lead to trials of risk-reducing interventions for patients with an elevated D-dimer level. This study, an exploratory, cross-sectional study of up to 200 subjects, seeks to prospectively collect data on D-dimer and related biomarkers in HIV-infected adults. Initially, the study will recruit HIV-infected adults with HIV viremia who are not taking antiretroviral therapy and compare their clinical histories and biomarker findings with those from (1) a group of HIV-infected adults with controlled HIV viremia who are receiving antiretroviral therapy, and with those from (2) a control group of HIV-negative healthy subjects. The study requires 2 visits for screening, history and physical examination, and phlebotomy. A wide array of research assays investigating different aspects of inflammation, coagulation, and endothelial function will be completed. Samples will be stored for future investigation.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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